Daiichi planning Japanese application for hypertension candidate

Daiichi Sankyo Co. Ltd. (Tokyo:4568) and Exelixis Inc. (NASDAQ:EXEL) said esaxerenone (CS-3150) met the primary endpoint in the Japanese Phase III ESAX-HTN trial to treat essential hypertension. In 1Q18, Daiichi plans to submit a regulatory application in Japan for the oral non-steroidal mineralocorticoid receptor antagonist in the indication.

In the 1,001-patient trial, once-daily oral esaxerenone significantly improved sitting systolic and diastolic blood pressure from baseline to week 12 vs. Inspra eplerenone. A secondary endpoint in the double-blind trial is the change from baseline in mean 24-hour systolic and diastolic blood pressure at week 12. Patients received once-daily Inspra or 2.5 or 5 mg esaxerenone. Daiichi plans to report detailed results at upcoming scientific meetings in 2018...